Educational Supplement for Prostate Cancer

Recruiting at 3 trial locations

Overseen By Viraj Master, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: RN or MD degree, Head injury, Dementia, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special educational guide can help patients better understand their treatment options and side effects after consulting with their doctor. It focuses on African American patients recently diagnosed with early-stage prostate cancer. The study seeks participants who have confirmed prostate cancer at specific hospitals and are in an early stage, specifically stage T1-T2, based on physical exams. This trial excludes medical professionals and individuals with significant cognitive issues. Participants will receive education to help interpret the information provided by their doctors. As an unphased trial, this study offers participants the chance to contribute to valuable educational research that could enhance patient care.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this educational supplement is safe for patients?

Research has shown that educational programs can enhance understanding of prostate cancer. One study found that a teaching method based on the health belief model increased knowledge about prostate cancer and improved health beliefs. Educational tools are generally safe and well-received, as they aim to inform and empower patients. No reports of negative effects have emerged from using educational materials in this context.

This trial employs an educational tool to help participants understand treatment options and side effects, and it is expected to be safe. Since the focus is on providing information rather than medication, safety concerns are minimal. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Educational Supplement for prostate cancer because it focuses on enhancing patient education, a crucial yet often overlooked aspect of treatment. Unlike traditional treatments that concentrate on medical interventions like surgery, radiation, or hormone therapy, this approach aims to empower patients with knowledge about their treatment options and potential side effects. This education can lead to better patient engagement, improved treatment adherence, and potentially better outcomes, as patients are better informed and can make decisions that align with their personal values and lifestyles.

What evidence suggests that this educational supplement is effective for improving understanding of prostate cancer treatment options?

Research has shown that educational materials can help prostate cancer patients better understand their treatment choices. In this trial, participants will receive an educational supplement designed to enhance their understanding of treatment options and side effects. A review of studies has found that these educational tools can improve the quality of life for men with prostate cancer. Another study found that education based on the health belief model increased patients' knowledge and confidence about their health. These findings suggest that educational resources could empower patients by improving their understanding and decision-making during treatment discussions. ^{1 2 3 6 7}

Who Is on the Research Team?

Kerry Kilbridge, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for newly diagnosed, early-stage African American prostate cancer patients who have had a pathology review of their prostate biopsy at specific hospitals in Atlanta with clinical stage T1-T2 cancer. It's not open to others.

Inclusion Criteria

My prostate cancer is in the early stages and was reviewed at a specified hospital.

Exclusion Criteria

RN or MD degree

History of head injury or dementia

History of cognitive impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants' comprehension of treatment options and side effects, as well as decisional conflict, are measured before any intervention

1 week

1 visit (in-person)

Intervention

Participants receive a low literacy educational supplement to improve understanding of treatment options and side effects

Up to 6 weeks

1 visit (in-person)

Post-Intervention Assessment

Participants' comprehension of treatment options and side effects, as well as decisional conflict, are measured after the intervention

1 week

1 visit (in-person)

Follow-up

Participants are monitored for any changes in comprehension and decisional conflict after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Educational Supplement
• Standard Practice Education

Trial Overview The study is observing if an educational supplement can help these patients better understand treatment options and side effects compared to standard education practices after they speak with their urologist.

How Is the Trial Designed?

Group I: Educational Supplement Experimental Treatment 2 Interventions

Participants diagnosed with prostate cancer will receive education for treatment options and treatment side effects.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11116859/

a systematic review This systematic review aimed to identify educational and psychological survivorship interventions targeting HRQoL outcomes for men with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10528560/

PMC Search Update - PubMed Central - NIH This study aims to explore the perceptions of patients regarding a 28-day online Prostate Cancer-Patient Empowerment Program (PC-PEP). The ...

3. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12044-9

Effect of health belief model-based educational intervention ... Our research objective was to investigate the effect of health belief model-based education on prostate cancer knowledge, health beliefs, and preventive health ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831323

Exercise and Psychosexual Education to Improve Sexual ... In this randomized clinical trial including 112 patients with prostate cancer, exercise improved erectile function compared with usual care.

5. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522046998

Men's health supplement use and outcomes in ... In summary, the data presented in this study underscore the likely inability of MHSs to improve the outcomes or toxicities of prostate cancer patients. We did ...

6. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/1104493

Vitamin E and the Risk of Prostate Cancer: The Selenium ... Conclusion Dietary supplementation with vitamin E significantly increased the risk of prostate cancer among healthy men. Trial Registration ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4322917/

Prevention of Prostate Cancer: Outcomes of Clinical Trials and ... Selenium supplementation has no effect on prostate cancer risk. Vitamin E supplementation significantly increases the risk of prostate cancer by 17%.